Tiltan Pharma Receives FDA Approval to Conducts its
Phase 2 Clinical Study of Anti-Angiogenic Treatment
for Pancreatic Cancer in the US
Jerusalem Israel – July 1, 2012 - Tiltan Pharma Ltd. today announced that the
FDA has granted an IND approval to Tiltan's application to conduct its Phase
2 clinical trial of its anti-angiogenic product TL-118 for the treatment of
pancreatic cancer, in the US.
Following an approval by the Israeli Ministry of Health, Tiltan Pharma has
launched the Phase 2 study in four major oncology centers in Israel and will
now expand it to the US. The clinical trial will enroll 80 patients with newly
diagnosed metastatic pancreatic cancer that have not yet been treated with
chemotherapy. The trial will include two arms with 40 subjects each. The
control group will be treated with standard chemotherapy for pancreatic
cancer, and the treated group will receive TL-118 in addition to standard-ofcare chemotherapy.
TL-118 was previously tested in a mouse model of pancreatic cancer. In preclinical trials, TL-118 monotherapy has been shown to inhibit tumor growth
significantly, compared to the standard-of-care chemotherapy. TL-118 therapy
in combination with the standard-of-care chemotherapy has been shown to
abolish the tumors in all treated animals.
TL-118 inhibits new blood vessel formations in tumors and thus inhibits their
blood supply and growth. TL-118 is an oral solution administered once daily
and comprises a combination of agents that target different, non-overlapping
aspects of the angiogenic process, all of which are approved by the regulatory
authorities. The therapy cycle is a carefully timed and balanced, patientfriendly, treatment regimen that maximizes the synergistic effect of these
agents and combines them into a singularly safe and effective cancer
treatment. Over 120 patients have been treated with TL-118 so far, for up to 3
years.
TL-118 was previously tested for safety in a Phase 1 clinical trial that was
conducted in the Sheba Medical Center at Tel-Hashomer, Israel. Thirty cancer
patients were enrolled in the trial and the therapy was found to be safe and
tolerable for the treatment of cancer patients and caused mostly minor
clinically significant adverse reactions.
Tiltan Pharma Ltd.
1-1 Hi-tech Village, Edmond Safra Campus, Givat Ram
P.O.B. 39026; Jerusalem 91390, Israel.
Tel: +972-54-555-8573
Fax: +972-3 -636-1025
Web:www.TiltanPharma.com
Tiltan Pharma will be included as one of the portfolio companies of Integra
Holdings, a holding company currently being formed by Yissum, the
technology transfer company of the Hebrew University of Jerusalem.
About Anti-Angiogenic Therapy
Angiogenesis is the process by which new blood vessels are formed and is a
hallmark capability of cancer. Anti-angiogenic therapy aiming to starve the
tumor by cutting off its blood supply has emerged as a most promising
strategy to inhibit tumor growth and spread, since solid tumors rely on
aggressive angiogenesis for their growth. In contrast to tumors, active
angiogenesis does not take place in healthy tissues, highlighting the
therapeutic potential and feasibility of anti-angiogenic therapy. TL-118 was
developed to inhibit several, non-overlapping, pathways that are involved in
angiogenesis.
About Pancreatic Cancer
Pancreatic cancer is the fourth most common cause of cancer-related death
for both genders combined in the western world. Recent estimates indicate
that approximately 44,000 new cases and deaths are expected to occur in the
US during 2011. For all the stages combined, the 5-year survival rate is only
6%, with even poorer prognosis for patients with advanced pancreatic cancer.
About Tiltan Pharma
Tiltan Pharma Ltd. is a biotechnology company dedicated to the development
and commercialization of its proprietary anti-angiogenic platform for the
treatment of cancer and other indications. The Company is jointly owned by
Yissum, the Technology Transfer Company of the Hebrew University, its
entrepreneurs, Israeli investors and a group of Canadian high net worth
investors. For additional information, please visit www.tiltanpharma.com
Company Contact:
Dan Goldstaub, Ph. D.
Chief Operating Officer
Tiltan Pharma Ltd.
Dan@TiltanPharma.com
Tiltan Pharma Ltd.
1-1 Hi-tech Village, Edmond Safra Campus, Givat Ram
P.O.B. 39026; Jerusalem 91390, Israel.
Tel: +972-54-555-8573
Fax: +972-3 -636-1025
Web:www.TiltanPharma.com